FDA.report

Polytel GMA

Primary DI
00861700000321
Brand
Polytel GMA
Company
Polymap Wireless
Model
PWR-08-09
Device description
Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Abbott. Specific meters supported are FreeStyle Lite and FreeStyle Freedom Lite
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00861700000321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00861700000321008617000003218617000003210861700000321

GMDN Terms

TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1 520 747 1811info@polymap.net

Regulatory Flags

DUNS number
108359188
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00861700000307Polytel GMAPWR-08-062016-08-02
00861700000314Polytel GMAPWR-08-072016-08-02
00861700000338Polytel GMA2PWR-09-022016-08-02
00861700000345Polytel"L" cable for GMA2RPLYX012017-02-15
00861700000352Polytel"A" cable for GMA2RPLYX022017-02-15
00861700000369Polytel"B" cable for GMA2RYPLX032017-02-15
00861700000376PolytelGMA2-L2017-03-08

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